FDA Device recall Z-1327-2020
OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
- FDA Device
- Class II
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class II recall of OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565 by The Binding Site Group, citing 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. Th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1327-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-29 |
| Published | 2020-02-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | The Binding Site Group |
| Distribution | 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 |
Product
OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
Reason
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.
Identifiers
| code_info | Lot # 422251 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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All The Binding Site Group recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1327-2020%22
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