Z-2821-2026Class II

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Intelligent...

Name: Z-2821-2026 Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Intelligent...
Creator: Instrumentation Laboratory
Published: 2026-05-08
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2026-05-08 / Open, Classified / root cause: software

FDA source

Instrumentation Laboratory began a recall of Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Intelligent Quality Management 2 (iQM2) is used as the quality... on 2026-05-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2821-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-08
Posted: 2026-07-29
Recalling firm: Instrumentation Laboratory Co.
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.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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.
Root cause tag: software
FDA root cause: Software Design Change
Action: 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.
Quantity in commerce: 0 US, 118 OUS
Distribution: US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2821-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2821-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-29
Z-2822-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-29
Z-2823-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-29
Z-2824-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-29
Z-2825-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-29
Z-2826-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-29

Product code CHL

K203790Class IIGEM Premier 5000Instrumentation Laboratory CO / cleared 2021-08-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)