medical MODERATE
Fish
Updated 2026-08-05

Instrumentation Laboratory recalls Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Pre

See all recalls from Instrumentation Laboratory →

Recalled Product

Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000. portable blood analyzer

Share this recall: Facebook X / Twitter WhatsApp Email

Hazard / Issue

Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GEM Premier 7000: Part number: 00000015279 UDI: 0195226000924 Units distributed in US: GEM Premier 7000 Serial Nos. 26012062, 26012065, 26012069 and 26012070. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for Brand Name: GEM Premier →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

Related medical Recalls

Instrumentation Laboratory recalls Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000

2026-08-05 · Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.

Argon Medical Devices, Inc recalls L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga

2026-08-05 · Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.

Stryker GmbH recalls Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog N

2026-08-05 · Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

Medtronic Perfusion Systems recalls EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intend

2026-08-05 · Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.