BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the… — Class II medical device recall Z-2048-2020
Terminated recall by Becton Dickinson & Co., reported 2020-05-27, distributed nationwide. May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, in
| Recall number | Z-2048-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2020-04-14 |
| Classified | 2020-05-19 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2022-02-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CL, CN, CR, HK, JP, KR, MX, NZ, SG, TH, TW |
| Quantity | 1,469 kits |
| Lot numbers | 0007255, 0007261, 0014322, 0028309, 0041114 |
| Model numbers | 212539 |
Product
BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
Reason for recall
May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram stain
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-2048-2020. 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.