Recall Z-2821-2026
- Recall number
- Z-2821-2026
- Event number
- 99115
- Firm
- Instrumentation Laboratory
- Firm FEI
- 1217183
- Product code
- CHL
- Status
- Open, Classified
- Initiated
- 2026-05-08
- Posted
- 2026-07-29
- Root cause
- Software Design Change
- 510(k) numbers
- K203790, K110416, K240998, K142220, K873577, K013729, K984384, K122539, K924497, K961657, K992834, K151982, K982928, K041874, K771253, K932642, K023567, K022746, K924758, K961335, K963964, K863880, K936203, K770736, K110648, K031560, K200107, K831023, K980130, K884267
Product#
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system.
Reason for Recall#
BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.