Medical Calcium Reagent Shipped Without Required Refrigeration; QC Failure Risk
A medical lab reagent (ABX Pentra Calcium AS CP) was shipped at room temperature instead of refrigerated, causing probable quality control failure. Affected patients may experience diagnostic delays and require repeat testing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is a quality control failure of a medical reagent that could result in incorrect diagnostic results, meeting the criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
ABX Pentra Calcium AS CP, Reagent 90 mL (Lot Numbers 215907578 and 215907729) manufactured by Medline Industries was shipped to a laboratory in North Carolina without the required refrigeration (ice). The reagent was stored and shipped at room temperature instead of the required cold storage, which compromises product quality.
If the affected reagent is used in testing, it will fail quality control checks and cannot provide reliable test results. This may delay patient diagnosis and require repeat blood tests, causing patient inconvenience and additional testing costs.
Six boxes were shipped to end users in this condition, and five additional boxes remain on hold at a Medline warehouse. Laboratories should check if they received product from the identified lots and verify whether any patient testing was performed with the affected product.
The recalled product
- Product
- ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- improper-storage
- quality-control-failure
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 (4)
- Model Number: HII1220001954
- Lot Numbers: 215907578 (Expiration Date 09/30/2022)
- 215907729 (Expiration Date 02/28/2023)
- Manufacturer Number: A11A01954
Distribution
Distribution scope not specified by the agency.
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