ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
Summary
The FDA issued a Class II for ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954 by MEDLINE INDUSTRIES, LP - Northfield. Reason: Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the result.
Details
Source
Device Recall
External ID
Z-1140-2022
Action Date
2022-06-01
Status
Terminated
Category
device
Product Description
ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
Lot/Code Info: Model Number: HII1220001954; Lot Numbers: 215907578 (Expiration Date 09/30/2022), 215907729 (Expiration Date 02/28/2023); Manufacturer Number: A11A01954
Quantity Affected: 6 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.
Distribution
US Distribution to North Carolina.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-22
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 139 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1140-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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