Reported Aug 5, 2026 · Ongoing
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer…
Instrumentation Laboratory
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Instrumentation Laboratory · 180 Hartwell Rd · Bedford, MA · 01730-2443
Is this the product you have?
- Brand NameGEM
- Premier 5000 Product NameGEM
- Premier 5000 Model/Catalog Number00024019255 portable blood analyzer system
- Lot codes and dates
- GEM Premier 5000Part
- number00024019255
- UDI08426950870227
- Units distributed in United Kingdom
66 of 66 codes
GEM Premier 5000 Serial Nos.: 251105472510046225110522251004722510189725101920251019312512202926012032251220302601203326012043251105232511053625120550250696382310110924011137250817992508179725091839250918402509186425091870250918682509187325091880250918762510188625101889251018872510189125101907251019042510191225101905251019172510192125101926251019292510193425101927251119682512198625121985251219812512198425121994251219952512198225121993251219912512199925121996160302551706078217060784170607851706078917060790
- Affected AccessoryBar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634
- Amount recalled
- 67
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
This product could cause temporary or reversible health problems — stop using it.
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