How do I get a refund or replacement for this recall?

Stop using the recalled product immediately. Follow the manufacturer's instructions on the official recall notice for returning or disposing of the product. Depending on the recall, you may receive a full refund, a replacement product, or a free repair. Visit the official source link on this page for claim instructions.

How do I know if my product is affected by this recall?

Check the product name, model number, lot number, or purchase date against the official recall notice. The official source link on this page contains the full list of affected units. If in doubt, stop using the product and contact the manufacturer directly.

Product Recalls & Refunds Online / National

Instrumentation Laboratory: GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+,

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer

Recall reason: Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications for pO2. The positive bias may lead to false positive for medical decision levels at pO2 < 60 mmHg, which may result in failure to detect and/or adequately treat hypoxemia and lead to a delay in treatment. The quality control procedures for the Non-iQM GEM Premier 3000 may not detect the non-conformance.. Recalled by Instrumentation Laboratory. Distribution: US States: MA, MN, NY. India.. Classification (Class II — potential health risk). Af

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer

Category Product Recalls & Refunds

Location National

Eligibility U.S. consumers who own or purchased the recalled medical device. Contact the manufacturer or the retailer/pharmacy where you purchased it to arrange for a free correction, repair, or replacement. Have the model number ready if possible.

Source Official Source ↗

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