Reported Nov 29, 2023 · Ongoing
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
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?
GEM Premier 3000 PAK - pHpCO2pO2HctPart Numbers 000243075040002433000400024345004
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 0002430750408426950087922UDI-DI: 08426950087922, Lot Numbers: 324230M, 323630G 0002433000408426950082507UDI-DI: 08426950082507, Lot Numbers: 325655C, 322355C, 323755H, 323855E, 326255D 0002434500408426950082538UDI-DI: 08426950082538, Lot Numbers: 325660C, 324160J, 323760H - Amount recalled
- 2448 total
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications for pO2. The positive bias may lead to false positive for medical decision levels at pO2 < 60 mmHg, which may result in failure to detect and/or adequately treat hypoxemia and lead to a delay in treatment. The quality control procedures for the Non-iQM GEM Premier 3000 may not detect the non-conformance.
This product could cause temporary or reversible health problems — stop using it.
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