CLASS II Device recall · Reported 2 Jun 2021 · FDA Enforcement Report
Access Sars-CoV-2 Antigen recalled by Beckman Coulter
Beckman Coulter is recalling Access Sars-CoV-2 Antigen, distributed nationwide in the US. The recall was initiated on 14 Apr 2021 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-1670-2021
- FDA event ID
- 87738
- Recalling firm
- Beckman Coulter, Brea, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Apr 2021
- FDA classified
- 21 May 2021
- Reported
- 2 Jun 2021
- 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
| 14 Apr 2021 | Recall initiated by company | |
| 21 May 2021 | Classified by FDA | +37 days |
| 2 Jun 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
specimens collected in transport media may result is false negative results when stored in certain conditions.
Product as listed by the FDA
Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of Alabama, Arizona, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, West Virginia and the country of New Zealand.
Nationwide AlabamaArkansasArizonaCaliforniaConnecticutDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMaineMichiganMississippiNorth Carolina
Questions about this recall
Is Access Sars-CoV-2 Antigen recalled?
Yes. Beckman Coulter recalled Access Sars-CoV-2 Antigen on 14 Apr 2021. The recall is Class II and its status is Terminated. Recall number Z-1670-2021.
Why was it recalled?
specimens collected in transport media may result is false negative results when stored in certain conditions.
Which lots are affected?
All Lots
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of Alabama, Arizona, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, West Virginia and the country of New Zealand.
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.
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|---|---|---|---|---|---|
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