Abbott Rapid DX Multi Analyte Control Affected by Storage Temperature Excursion
Abbott Rapid DX Multi Analyte Level 1 & 2 control products were exposed to temperatures outside recommended storage conditions due to transit delays caused by severe thunderstorms, which may result in incorrect or delayed test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard is a temporary storage condition failure that may affect test accuracy, which is a quality/performance issue rather than an immediate safety threat. The precautionary nature of the recall and absence of confirmed harm support a Moderate severity classification.
Plain-English summary
Abbott Rapid DX Multi Analyte Level 1 & 2 250µL Cholesterol Control products are being recalled due to transit delays caused by severe thunderstorms that resulted in storage outside the manufacturer's recommended labeled storage conditions.
This storage temperature excursion may increase the probability of incorrect test results or delayed test results when the product is used.
The recalled products were distributed nationwide in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. The affected product has Catalog No. 88773, GTIN 893038002036, and Order No. 46108009.
Customers should contact their Mckesson Medical-Surgical representative or the manufacturer for guidance on affected units and appropriate corrective actions.
The recalled product
- Product
- ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalog No. 88773
- GTIN: 893038002036
- Order No. 46108009.
Distribution
Part of a larger recall action
This product is one of 32 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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