OPTILITE IgM Kit — Class II medical device recall Z-1327-2020
Terminated recall by The Binding Site Group, Ltd., reported 2020-02-26, distributed in AL, AR, AZ, CA, FL, GA, IA, IL…. There is a potential that users may experience difficulty validating the calibration of the kit. This is indic
| Recall number | Z-1327-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Binding Site Group, Ltd., Birmingham, United Kingdom |
| Recall initiated | 2019-07-29 |
| Classified | 2020-02-19 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2022-01-13 |
| Distributed | AL, AR, AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MI, MN, NC, NE, NY, OH, OR, PA, SC, SD, TN, TX, UT, VT, WA, WV |
| Quantity | 3,294 kits |
| UPC / GTIN / UDI-DI | 05051700017565 |
| Lot numbers | 422251 |
| Model numbers | NK012.OPT.A |
Product
OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
Reason for recall
There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.
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-1327-2020. 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.