Recall Z-1140-2022— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1140-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-22

Class II · Terminated

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2021-10-22, terminated 2023-01-04. It names one FDA 510(k) clearance: K060205. Product: ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954. Reason: 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..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Terminated
Initiated: 2021-10-22
Terminated: 2023-01-04
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K060205 — GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERHoriba Abx·cleared 2006-07-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.