Instrumentation Laboratory: Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Product Description: The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples. Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system. iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during, and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls (QC). Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed. The GEM Premier 5000 system makes use of potentiometric sensors to measure pCO2, pH, Na+, K+, Cl-, and Ca++. It uses amperometric sensors to measure pO2, glucose, and lactate concentrations. Blood conductivity is the method used to measure hematocrit. CO-Oximetry and total bilirubin measurements involve chemically lysing the whole blood sample and then utilizing a broad spectrum spectrophotometer to evaluate the sample at a variety of wavelengths.

Recall number

Z-2823-2026

Recalling firm

Instrumentation Laboratory

Product

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Product Description: The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples. Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system. iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during, and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls (QC). Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed. The GEM Premier 5000 system makes use of potentiometric sensors to measure pCO2, pH, Na+, K+, Cl-, and Ca++. It uses amperometric sensors to measure pO2, glucose, and lactate concentrations. Blood conductivity is the method used to measure hematocrit. CO-Oximetry and total bilirubin measurements involve chemically lysing the whole blood sample and then utilizing a broad spectrum spectrophotometer to evaluate the sample at a variety of wavelengths.

Status

Open, Classified

Initiated

2026-05-08

Posted

2026-07-29

Terminated

not on file

Reason

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

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

27

Distribution

US Nationwide distribution.

Lot, serial or model codes

Lot Code: GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 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. Affected Accessory: Bar Code Reader (BCR) Wand Part number: 00024019255 UDI: 08426950870227 Units distributed in Hong Kong: 27

510(k) numbers

["K203790"]

PMA numbers

not on file

Product code

CHL

Firm FEI

1217183

Firm city

Bedford

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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