CLASS II Device recall · Reported 4 Nov 2020 · FDA Enforcement Report

The Quidel Triage BNP Calibrators recalled by Medline Industries

Medline Industries is recalling The Quidel Triage BNP Calibrators, distributed in California, New York, Texas, Virginia. The recall was initiated on 1 Oct 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: ALR98202 Expiration date: Lot 832243, exp date 12/31/19 Lot 832570, exp date 03/31/20 Lot 921292, exp date 08/31/20 Lot 921565, exp date 12/31/20 Lot 921836, exp date 02/28/21 Lot 922069, exp date 03/31/21

Quantity recalled26 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0297-2021
FDA event ID: 86560
Recalling firm: Medline Industries, Northfield, IL
Classification: Class II
Status: Terminated
Recall initiated: 1 Oct 2020
FDA classified: 26 Oct 2020
Reported: 4 Nov 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

1 Oct 2020	Recall initiated by company
26 Oct 2020	Classified by FDA	+25 days
4 Nov 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product compromised during shipment.

Product as listed by the FDA

The Quidel Triage BNP Calibrators

Where it was distributed

Domestic Distribution only to: CA, NY, TX and VA

California New York Texas Virginia

Questions about this recall

Why was it recalled?

Product compromised during shipment.

Which lots are affected?

Model Number: ALR98202 Expiration date: Lot 832243, exp date 12/31/19 Lot 832570, exp date 03/31/20 Lot 921292, exp date 08/31/20 Lot 921565, exp date 12/31/20 Lot 921836, exp date 02/28/21 Lot 922069, exp date 03/31/21

Where was it sold?

Domestic Distribution only to: CA, NY, TX and VA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Medline Industries

All 686

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ortho Aspiration Kit recalled	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled	Medline Industries	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Arterial Line Insertion Kit recalled	Medline Industries	Sterility	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide