FDAClass II · Medical device · Recall Z-2826-2026 · Recalled August 5, 2026

Brand Name recall — Instrumentation Laboratory

Agency report date: August 5, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Brand Name
Company / brand: Instrumentation Laboratory
Lot / serial / date codes: GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in Argentina: GEM Premier 5000 Serial Nos.: 25100466, 24097933 and 23064897. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634
Distribution: US Nationwide distribution.

Agency product description and boundaries

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Brand Name

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2826-2026
Brand: Instrumentation Laboratory
Classification: Class II
Units affected: 3
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Brand Name

Companies & origin

Recalling firm location: Bedford, MA, United States
Firm address: 180 Hartwell Rd, N/A, 01730-2443

Identifying details (verbatim from the notice)

Product codes / lots: GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in Argentina: GEM Premier 5000 Serial Nos.: 25100466, 24097933 and 23064897. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634
Distribution: US Nationwide distribution.
Firm notified the public via: Letter
FDA event ID: 99115
Recall initiated: May 8, 2026
FDA classified: July 29, 2026
FDA report date: August 5, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved September 7, 2026 at 6:00 AM UTC.

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