GREER M — Class II medical device recall Z-0347-2023
Terminated recall by Greer Laboratories, Inc., reported 2022-12-07, distributed in CA, CO, IA, KY, MA, MD, MO, NC…. The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that coul
| Recall number | Z-0347-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Greer Laboratories, Inc., Lenoir, NC, United States |
| Recall initiated | 2022-10-25 |
| Classified | 2022-11-30 |
| Reported by FDA | 2022-12-07 |
| Terminated | 2026-02-11 |
| Distributed | CA, CO, IA, KY, MA, MD, MO, NC, PA, UT, VA |
| Countries outside the US | CA, DK |
| Quantity | 218 units |
| Reason classes | potency, specification failure |
| Lot numbers | 389591 |
| Expiration dates | 2023-06-12 |
Product
GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0347-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.