CLASS II Device recall · Reported 7 Dec 2022 · FDA Enforcement Report
Greer Dia - Kit Antigen M recalled by Greer Laboratories
Greer Laboratories is recalling Greer Dia - Kit Antigen M, distributed nationwide in the US. The recall was initiated on 25 Oct 2022 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-0348-2023
- FDA event ID
- 91078
- Recalling firm
- Greer Laboratories, Lenoir, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Oct 2022
- FDA classified
- 30 Nov 2022
- Reported
- 7 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Lead & Heavy Metals
- Device type
- Test Kits & Diagnostics
Timeline
| 25 Oct 2022 | Recall initiated by company | |
| 30 Nov 2022 | Classified by FDA | +36 days |
| 7 Dec 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that could lead to a potential false-negative result interpretation. The issue was identified by the firm after failing to meet lot requirements for potency. The lot release error was discovered on October 08, 2021, after a failed potency test was determined during 6-month stability evaluation of retention material for the lots. The subsequent manufacturing investigation, which included a review of the lot release potency documentation, found that the initial lot release potency test for the lot was misinterpreted.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.
Where it was distributed
US Distribution to states of: CA, CO, IA, KY, MA, MD, MO, NC, PA, UT, VA, and International to countries of: Canada, Denmark
Nationwide CaliforniaColoradoIowaKentuckyMassachusettsMarylandMissouriNorth CarolinaPennsylvaniaUtahVirginia
Questions about this recall
Is Greer Dia - Kit Antigen M recalled?
Yes. Greer Laboratories recalled Greer Dia - Kit Antigen M on 25 Oct 2022. The recall is Class II and its status is Terminated. Recall number Z-0348-2023.
Why was it recalled?
The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that could lead to a potential false-negative result interpretation. The issue was identified by the firm after failing to meet lot requirements for potency. The lot release error was discovered on October 08, 2021, after a failed potency test was determined during 6-month stability evaluation of retention material for the lots. The subsequent manufacturing investigation, which included a review of the lot release potency documentation, found that the initial lot release potency test for the lot was misinterpreted.
Which lots are affected?
Lot Number 389592, exp 6/12/2023
Where was it sold?
US Distribution to states of: CA, CO, IA, KY, MA, MD, MO, NC, PA, UT, VA, and International to countries of: Canada, Denmark
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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