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Iq calibrator pack and control focus set

Official notice

14 Mar 2022

Last checked

14 Mar 2022

Medium riskHealth Canada

An official Health Canada notice concerns Iq calibrator pack and control focus set. Beckman Coulter has identified that order number(s) 41231574 and 41231557 for the shipment of Iq200 Control/Focus Set (part number 800-3104, lot# 146-21) and Iq200 Calibrator (part number 800-3103, lot# 146-21) were inadvertently frozen prior to shipment. There is a potential that the red blood cells (RBC) in the products will degrade after a freeze/thaw cycle. Recall start date: Nov 8, 2021 Published 2022-03-14.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63980

Official notice

2022-03-14

The hazard

Beckman Coulter has identified that order number(s) 41231574 and 41231557 for the shipment of Iq200 Control/Focus Set (part number 800-3104, lot# 146-21) and Iq200 Calibrator (part number 800-3103, lot# 146-21) were inadvertently frozen prior to shipment. There is a potential that the red blood cells (RBC) in the products will degrade after a freeze/thaw cycle. Recall start date: Nov 8, 2021

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

146-21

Recall Numbers

63980

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Affected products

Product 1

Affected Products - Iq Control/Focus Set, Lot or Serial Number - 146-21, Model or catalog number - 800-3104

Product 2

Affected Products - Iq Calibrator Pack, Lot or Serial Number - 146-21, Model or catalog number - 800-3103

Risk / hazard

Beckman Coulter has identified that order number(s) 41231574 and 41231557 for the shipment of Iq200 Control/Focus Set (part number 800-3104, lot# 146-21) and Iq200 Calibrator (part number 800-3103, lot# 146-21) were inadvertently frozen prior to shipment. There is a potential that the red blood cells (RBC) in the products will degrade after a freeze/thaw cycle. Recall start date: Nov 8, 2021

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Beckman Coulter, Iq Calibrator Pack And Control Focus Set.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

63980

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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