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Terminated

ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954

FDA Recall Z-1140-2022 · Posted None

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusTerminated
Product CodeCIC
Date Initiated2021-10-22
Date Terminated2023-01-04
Product Quantity6 boxes

Reason for Recall

Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from this impacted Calcium reagent will not be provided due to probable Quality Control failure. A delay in diagnosis may be experienced with repeat testing resulting in patient (customer) inconvenience, pain, and cost of the repeat blood draw and testing. All HII1220001954 product shipped/stored at a Medline branch between July 2021 and August 2021 in the identified lots were incorrectly stored and shipped. Six (6) boxes have been shipped to end users at room temperature instead of refrigerated (ice). Five (5) boxes are on hold at a Medline warehouse.

Firm Action

Medline contacted affected consignee via telephone on 10/22/2021 and confirmed that the product had been destroyed.

Root Cause

Process control

Distribution Pattern

US Distribution to North Carolina.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060205GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERHoriba Abx · 2006-07-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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