CLASS II Device recall · Reported 5 Sep 2018 · FDA Enforcement Report
Roche cobas p 612 pre-analytical system (63x) recalled
Roche Diagnostics is recalling Roche cobas p 612 pre-analytical system (63x), distributed in California, New York, Texas, Washington, Wisconsin. The recall was initiated on 16 Jul 2018 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-2944-2018
- FDA event ID
- 80617
- Recalling firm
- Roche Diagnostics, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jul 2018
- FDA classified
- 27 Aug 2018
- Reported
- 5 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 16 Jul 2018 | Recall initiated by company | |
| 27 Aug 2018 | Classified by FDA | +42 days |
| 5 Sep 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sample material may potentially come in contact with the pipetting nozzle during operation of cobas p 612 pre-analytical system (63x) (LCP1) with non-filter tips. The possible presence of biological material on the nozzle may cause contamination resulting in potential false positive results, depending on the sensitivity of the analytical technology.
Product as listed by the FDA
Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged and non-centrifuged sample tubes. The cobas p 612 is intended for use with analyzers that perform tests in the area of clinical chemistry, immuno chemistry, coagulation, hematology, urinalysis, nucleic acid testing.
Where it was distributed
US Distribution to states of: CA, NY,TX, WA, and WI.
Questions about this recall
Is Roche cobas p 612 pre-analytical system (63x) recalled?
Yes. Roche Diagnostics recalled Roche cobas p 612 pre-analytical system (63x) on 16 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-2944-2018.
Why was it recalled?
Sample material may potentially come in contact with the pipetting nozzle during operation of cobas p 612 pre-analytical system (63x) (LCP1) with non-filter tips. The possible presence of biological material on the nozzle may cause contamination resulting in potential false positive results, depending on the sensitivity of the analytical technology.
Which lots are affected?
All units
Where was it sold?
US Distribution to states of: CA, NY,TX, WA, and WI.
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 21 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 Roche Diagnostics
All 39| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | The Tina-quant lgA Gen.2 is an immunoturbidimetric assay recalled | Roche Diagnostics | Potency & Assay | AL, IN, KY |
| Device | CLASS III | cobas p 701 post-analytical units recalled by Roche Diagnostics | Roche Diagnostics | Other | Nationwide |
| Device | CLASS III | cobas p 501 post-analytical units recalled by Roche Diagnostics | Roche Diagnostics | Other | Nationwide |
| Device | CLASS II | Cobas¿ infinity central lab IT solution Material Number recalled | Roche Diagnostics | Device Malfunction | 11 states |
| Device | CLASS II | cobas e 801 immunoassay analyzer recalled by Roche Diagnostics | Roche Diagnostics | Lead & Heavy Metals | 26 states |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein S recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |