Z-1140-2022Class II

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

Name: Z-1140-2022 ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2021-10-22
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2021-10-22 / Terminated / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954 on 2021-10-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1140-2022
Classification: Class II
Status: Terminated
Initiated: 2021-10-22
Posted: 2022-05-26
Terminated: 2023-01-04
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
Product code: CIC Cresolphthalein Complexone, Calcium
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medline contacted affected consignee via telephone on 10/22/2021 and confirmed that the product had been destroyed.
Quantity in commerce: 6 boxes
Distribution: US Distribution to North Carolina.
Product codes and lots: Model Number: HII1220001954; Lot Numbers: 215907578 (Expiration Date 09/30/2022), 215907729 (Expiration Date 02/28/2023); Manufacturer Number: A11A01954

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1140-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1140-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-01	2022-05-26

Product code CIC

K060205Class IIGeneral Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx / cleared 2006-07-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)