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U.S. Department of Health and Human Services

Class 2 Device Recall GEM Premier 5000

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 Class 2 Device Recall GEM Premier 5000see related information
Date Initiated by FirmMay 08, 2026
Date PostedJuly 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2821-2026
Recall Event ID 99115
510(K)NumberK203790 
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
ProductBrand 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.
Code Information Lot Code: GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in US: 0 affected BCR wands on the GEM Premier 5000 in the US. GEM Premier 5000 Serial Nos.: N/A Units distributed in Hong Kong: 27 affected BCR wands on the GEM Premier 5000 in Hong Kong. GEM Premier 5000 Serial Nos.: 20106073, 20106039, 19052933, 20116415, 20064792, 22062065, 22062067, 19103490, 22092716, 22102881, 18112339, 19012518, 20126582, 20075256, 20064794, 20106036, 24016057, 21088758, 21088759, 18061910, 24016081, 24016108, 24108036, 24108044, 24067370, 24067371 and 24077468. Units distributed in United Kingdom: 67 affected BCR wands on the GEM Premier 5000 in the United Kingdom. GEM Premier 5000 Serial Nos.: 25110547, 25100462, 25110522, 25100472, 25101897, 25101920, 25101931, 25122029, 26012032, 25122030, 26012033, 26012043, 25110523, 25110536, 25120550, 25069638, 23101109, 24011137, 25081799, 25081797, 25091839, 25091840, 25091864, 25091870, 25091868, 25091873, 25091880, 25091876, 25101886, 25101889, 25101887, 25101891, 25101907, 25101904, 25101912, 25101905, 25101917, 25101921, 25101926, 25101929, 25101934, 25101927, 25111968, 25121986, 25121985, 25121981, 25121984, 25121994, 25121995, 25121982, 25121993, 25121991, 25121999, 25121996, 16030255, 17060782, 17060784, 17060785, 17060789, 17060790, 17060797, 17111126, 17121258, 18011414, 20054515, 20054516 and 22082271. Units distributed in Spain: 21 affected BCR wands on the GEM Premier 5000 in Spain. GEM Premier 5000 Serial Nos.: 25028719, 18021546, 18021549, 26012036, 18051850, 23054764, 21068342, 25080219, 26010781, 25122012, 25041639, 25120558, 25079944, 25079943, 25028719, 25100485, 25079947, 25100483, 25100484, 21057870 and 26010710. Units distributed in Argentina: 3 affected BCR wands on the GEM Premier 5000 in Argentina. GEM Premier 5000 Serial Nos.: 25100466, 24097933 and 23064897. Affected Accessory: Bar Code Reader (BCR) Wand Part number: 00024019255 UDI: 08426950870227 Units distributed in US: 0 Units distributed in Hong Kong: 27 Units distributed in Spain: 21 Units distributed in the United Kingdom: 67 Units distributed in Argentina: 3
FEI Number 1217183
Recalling Firm/
Manufacturer		 Instrumentation Laboratory
180 Hartwell Rd
Bedford MA 01730-2443
For Additional Information Contact
781-861-4467
Manufacturer 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.
FDA Determined
Cause 2		Software Design Change
ActionWerfen 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.
Quantity in Commerce0 US, 118 OUS
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CHL
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