CLASS II Device recall · Reported 27 Jan 2021 · FDA Enforcement Report
Access Sars-CoV-2 IgG QC Sars-CoV-2 IgG recalled by Beckman Coulter
Beckman Coulter is recalling Access Sars-CoV-2 IgG QC Sars-CoV-2 IgG, distributed nationwide in the US. The recall was initiated on 30 Dec 2020 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-0875-2021
- FDA event ID
- 87146
- Recalling firm
- Beckman Coulter, Brea, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Dec 2020
- FDA classified
- 15 Jan 2021
- Reported
- 27 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Processing Deviation
- Device type
- Test Kits & Diagnostics
Timeline
| 30 Dec 2020 | Recall initiated by company | |
| 15 Jan 2021 | Classified by FDA | +16 days |
| 27 Jan 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.
Where it was distributed
Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, FL, GA, IA, ID, IL, IN, KS,KY, LA, MD, MI, MN, MO, NC, ND, NY, OH, OK, OR, PA, Puerto Rico, SD, TX, WA, and WV. The countries of Andorra, Belgium, Brazil, Bulgaria, Canada*, Croatia, France, Germany, Hong Kong, Italy, Jordan, Mexico, Paraguay, Poland, Portugal, Romania, Spain, and United Kingdom.
Nationwide AlabamaArizonaCaliforniaFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMarylandMichiganMinnesotaMissouriNorth CarolinaNorth DakotaNew YorkOhio
Questions about this recall
Why was it recalled?
The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.
Which lots are affected?
Catalog Number: C58964 UDI Code: 15099590738662 Lot Number: 922407
Where was it sold?
Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, FL, GA, IA, ID, IL, IN, KS,KY, LA, MD, MI, MN, MO, NC, ND, NY, OH, OK, OR, PA, Puerto Rico, SD, TX, WA, and WV. The countries of Andorra, Belgium, Brazil, Bulgaria, Canada*, Croatia, France, Germany, Hong Kong, Italy, Jordan, Mexico, Paraguay, Poland, Portugal, Romania, Spain, and United Kingdom.
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.
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