GEM Premier 5000 PAK — Class II medical device recall Z-1530-2026
Ongoing recall by Instrumentation Laboratory, reported 2026-03-18, distributed nationwide. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an
| Recall number | Z-1530-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory, Bedford, MA, United States |
| Recall initiated | 2026-01-20 |
| Classified | 2026-03-10 |
| Reported by FDA | 2026-03-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JO, JP, KR, LB, LT, LU, LV, MX, MY, NL, NZ, OM, PA, PE, PH, PL, PT, QA, RO, RS, SA, SE, SG, SI, TH, TN, TR, UY, VN, ZA |
| Quantity | 1,126 units |
| UPC / GTIN / UDI-DI | 08426950807636 |
| Lot numbers | 251114J, 251117AC, 251117T, 251118B, 251119B, 251121P, 251124O, 251124Q, 251126E, 251201U, 251201V, 251201W, 251202G, 251203H, 251203L, 251204N, 251204O, 251205L, 251208I, 251208J, 251215Y, 251215Z, 251216V, 251217L, 251217X, 251218AA, 251218Y, 251219G, 251219M, 251219N, 251219S, 251222E, 251223D, 251223I, 251223N, 251223O, 251229J, 251229L, 251229U, 251231E |
| Model numbers | 00055407510 |
Product
GEM Premier 5000 PAK; Part No. 00055407510.
Reason for recall
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.
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-1530-2026. 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.