Sentinel CH recalls Alinity c Lithium Reagent Kits (lot numbers 80553Y600, 80444Y600, etc.) that may cause falsely elevated lithium test results due to carryover from LDH reagent. Consumers should contact Sentinel CH for details.
Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results
Sentinel CH is recalling Alinity c Lithium Reagent Kits that could cause false high lithium test results if used with certain other reagents. This affects lab tests for lithium levels in blood and may lead to incorrect medical decisions.
The reagent kits may cause carryover from a different reagent (LDH) that leads to falsely elevated lithium test results. This could cause incorrect medical decisions if the test is used for lithium level monitoring.
Lab users who test lithium levels in blood with the Alinity c analyzer using the recalled reagent kits. Those with medical conditions requiring precise lithium monitoring are most at risk.
Check the lot number on the reagent kit label: 80553Y600, 80444Y600, 80625Y600, or 90224Y600. The kits are sold with the ARCHITECT c Systems and Alinity c analyzer.
Look for lot numbers 80553Y600, 80444Y600, 80625Y600, or 90224Y600 on the reagent kit label.
Reach out to Sentinel CH for specific instructions on whether to stop using the kit or get a replacement.
The reagent kit may cause carryover from the LDH reagent, leading to falsely elevated lithium test results.
Check the lot number on the kit label. If it matches the recalled numbers, contact Sentinel CH for instructions.
This is a lab testing error risk, not a direct safety hazard. It could lead to incorrect medical decisions but does not cause injury.
We’ve drafted a message you can send Sentinel CH to request your refund or repair — edit it as you like.
Subject: Recall Z-2552-2019 — Sentinel CH Sentinel CH Hello, I own a Sentinel CH that is covered by recall Z-2552-2019 from Sentinel CH. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
