Reported Mar 18, 2026 · Ongoing
GEM Premier 5000 PAK; Part No. 00055415004.
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 PAKPart No. 00055415004
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 00055415004— — 08426950807650UDI: 08426950807650 — Lots No.: 251111O, 251112P, 251113U, 251117AD, 251118D, 251119D, 251120X, 251124Z, 251125S, 251201AI, 251202Q, 251203Q, 251208AA, 251209T, 251212O, 251216K, 251217I, 251217J, 251219R, 251222U, 251223E, 251229AG, 251229X, 251230P, 260102F. - Amount recalled
- 352 units
This recall covers 20 products
The agency filed one notice per product. You are reading one of them; the other 19 are below.
7 more are in the archive.
Where it was sold
- Nationwide
- GA
Why it was recalled
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
This product could cause temporary or reversible health problems — stop using it.
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