—#193532

Product

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

FDA product code: CIC — Cresolphthalein Complexone, Calcium
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K060205
Affected lot / code info: Model Number: HII1220001954; Lot Numbers: 215907578 (Expiration Date 09/30/2022), 215907729 (Expiration Date 02/28/2023); Manufacturer Number: A11A01954

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Distribution to North Carolina.

Timeline

Recall initiated: 2021-10-22
Terminated: 2023-01-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #193532. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.