CLASS II Device recall · Reported 5 Jun 2019 · FDA Enforcement Report
Alinity i Processing Module, 03R65 01, with the below components recalled
Abbott Gmbh & Co. KG is recalling Alinity i Processing Module, 03R65 01, with the below components, distributed nationwide in the US. The recall was initiated on 5 Apr 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1497-2019
- FDA event ID
- 82595
- Recalling firm
- Abbott Gmbh & Co. KG, Wiesbaden, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Apr 2019
- FDA classified
- 30 May 2019
- Reported
- 5 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Test Kits & Diagnostics
Timeline
| 5 Apr 2019 | Recall initiated by company | |
| 30 May 2019 | Classified by FDA | +55 days |
| 5 Jun 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential loose cable connections on the reagent cooler, which could result in temperature errors and eventual reagent cooler failure. Could cause burn and shock injuries to users and a delay in test results. Device design has mitigated this risk, but it is a possibility.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
Where it was distributed
Worldwide Distribution - US Nationwide to Oklahoma and Texas. Distributed worldwide to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, MADAGASCAR, MEXICO, NETHERLANDS, NORWAY, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SERBIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY, UAE, UNITED KINGDOM, VIETNAM.
Questions about this recall
Why was it recalled?
Potential loose cable connections on the reagent cooler, which could result in temperature errors and eventual reagent cooler failure. Could cause burn and shock injuries to users and a delay in test results. Device design has mitigated this risk, but it is a possibility.
Which lots are affected?
Part Number: 03R65 01, all Serial Numbers; a. TED (Thermo Electric Device) Engine, Reagent cooler - Part Numbers A 30103732 01, A 30103732 02 with all Serial Numbers; b. CABLE, POWER OUT, TED CNTRLER - Part Numbers A 35006203 01, A 35006203 02 with all Serial Numbers
Where was it sold?
Worldwide Distribution - US Nationwide to Oklahoma and Texas. Distributed worldwide to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, MADAGASCAR, MEXICO, NETHERLANDS, NORWAY, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SERBIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY, UAE, UNITED KINGDOM, VIETNAM.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Abbott Gmbh & Co. KG
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Alinity ci series System Control Module (SCM) recalled | Abbott Gmbh & Co. KG | Device Malfunction | Nationwide |
| Device | CLASS II | Alinity C, Processing Module recalled by Abbott Gmbh & Co. KG | Abbott Gmbh & Co. KG | Potency & Assay | 25 states |
| Device | CLASS II | Architect iGentamicin Reagent Kit recalled by Abbott Gmbh & Co. KG | Abbott Gmbh & Co. KG | Potency & Assay | Nationwide |
| Device | CLASS II | Architect Havab G Reagent Kit recalled by Abbott Gmbh & Co. KG | Abbott Gmbh & Co. KG | Hepatitis A | Nationwide |
| Device | CLASS II | LN 3R70 recalled by Abbott Gmbh & Co. KG | Abbott Gmbh & Co. KG | Device Malfunction | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,668| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MAS Omni Immune PRO Liquid Assayed Integrated Immunoassay recalled | Microgenics | Potency & Assay | Nationwide |
| Device | CLASS II | The ABL90 Flex and ABL90 Flex Plus analyzers are intended recalled | Radiometer Medical ApS | Labeling Errors | Nationwide |
| Device | CLASS I | HemoslL AcuStar HIT-lgG(PF-4) recalled by Instrumentation Laboratory | Instrumentation Laboratory | Other | Nationwide |
| Device | CLASS III | LeadCare II Blood Lead Test Kit recalled by Magellan Diagnostics | Magellan Diagnostics | Other | Nationwide |
| Device | CLASS I | HemoslL AcuStar HIT-lgG(PF-4) recalled by Instrumentation Laboratory | Instrumentation Laboratory | Other | Nationwide |