Reported Aug 12, 2026 · Ongoing · Updated Sep 16, 2026
GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010…
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 5000 PAK Part Numbers
000553600100005536001100055407504000554150100005543001000055430011000554450100005544501100055360010.A
- Lot codes and dates
9 of 9 products
Products covered by this recall Model / number Barcodes Product as published 0005536001008426950807599UDI-DI 08426950807599 Lots 260505K, 260504AG, 260505F 0005536001108426950807605UDI-DI 08426950807605 Lots 260505F and 260505J 0005540750408426950807537UDI-DI 08426950807537 Lot 260505R 0005541501008426950807698UDI-DI 08426950807698 Lots 260505H and 260505K 0005543001008426950807759UDI-DI 08426950807759 Lots 260505H, 260505K and 260505F 0005543001108426950807766UDI-DI 08426950807766 Lot 260505K — 08426950807810Product No. 00055445010 UDI-DI 08426950807810 Lots 260504AA and 260505K — 08426950807827Product No. 00055445011 UDI-DI 08426950807827 Lots 260505F and 260505J — 08426950807599Product No. 00055360010.A UDI-DI 08426950807599 Lot 260504AF - Amount recalled
- 109 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
This product could cause temporary or reversible health problems — stop using it.
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