CLASS II Device recall · Reported 12 Jun 2019 · FDA Enforcement Report
Alinity c Cuvette Segments, List Number 04S47 recalled
Abbott Gmbh & Co. KG is recalling Alinity c Cuvette Segments, List Number 04S47-01, distributed nationwide in the US. The recall was initiated on 15 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-1709-2019
- FDA event ID
- 82644
- Recalling firm
- Abbott Gmbh & Co. KG, Wiesbaden
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Apr 2019
- FDA classified
- 2 Jun 2019
- Reported
- 12 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 15 Apr 2019 | Recall initiated by company | |
| 2 Jun 2019 | Classified by FDA | +48 days |
| 12 Jun 2019 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Individual cuvettes within the Alinity c Cuvette Segment may become seated lower than the designed height. This may result in inadequate dispense into specific cuvettes due to the sample probe being unable to make efficient contact with the cuvette bottom.
Product as listed by the FDA
Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology.
Where it was distributed
US Nationwide Distribution- AL, AR,CA, FL, GA, IL, LA, MA, ME, MN, MO, NJ, NY, OK, SC, TN, TX, UT, & VA WORLDWIDE - Albania, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Czech Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, Norway, Pakistan, Philippines, Poland, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Thailand, Trinidad & Tobago, Turkey, United Kingdom, and Vietnam.
Nationwide AlabamaArkansasCaliforniaFloridaGeorgiaIllinoisLouisianaMassachusettsMaineMinnesotaMissouriNew JerseyNew YorkOklahomaPuerto RicoSouth CarolinaTennesseeTexasUtahVirginia
Questions about this recall
Why was it recalled?
Individual cuvettes within the Alinity c Cuvette Segment may become seated lower than the designed height. This may result in inadequate dispense into specific cuvettes due to the sample probe being unable to make efficient contact with the cuvette bottom.
Which lots are affected?
All serial numbers
Where was it sold?
US Nationwide Distribution- AL, AR,CA, FL, GA, IL, LA, MA, ME, MN, MO, NJ, NY, OK, SC, TN, TX, UT, & VA WORLDWIDE - Albania, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Czech Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, Norway, Pakistan, Philippines, Poland, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Thailand, Trinidad & Tobago, Turkey, United Kingdom, and 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 |