Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Product Description: The G
FDA device recall Z-2826-2026 · posted 2026-07-29 · Open, Classified
Recall details
- Recalling firm
- Instrumentation Laboratory
- 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.
- Action taken
- Werfen dba Instrumentation laboratory notified consignees on about 05/08/2026 via letter and/or email. Consignees were instructed to discontinue use of the affected BCR wands immediately, manually enter patient IDs when performing testing on the GEM Premier 5000 and/or 7000 until the BCR wands have been replaced, contact Werfen Service at 1-800-955-9525 to arrange for prompt replacement of the affected BCR wands, post this notification on or near affected GEM Premier 5000 and/or 7000 instruments, and inform all laboratory staff of this notification. Consignees were also instructed to forward the notification to all affected locations within each facility, retain a copy of the notification for records, and complete and return the Mandatory Response Tracking Form within 10 days of receipt. In addition to the tracked customer notification, a Service Information (SI) 2026-09 was issued on May 11, 2026, for service personnel to track the destruction of the affected BCR wands. The Service Information includes a destruction form for service personnel to document the destruction of the affected BCR wands and to return the form to Regulatory for tracking purposes.
- Root cause
- Software Design Change
- Status
- Open, Classified
- Product code
- CHL
- Quantity affected
- 3
- Distribution
- US Nationwide distribution.
- Date initiated
- 2026-05-08
- Date posted
- 2026-07-29
- Location
- Bedford, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEM Premier 5000 (K203790) | Instrumentation Laboratory CO | 2021-08-20 |