Z-1970-2023Class II

SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal...

Name: Z-1970-2023 SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal...
Creator: LumiraDx
Published: 2023-04-25
License: https://open.fda.gov/license/

LumiraDx / initiated 2023-04-25 / Open, Classified / root cause: manufacturing process

FDA source

LumiraDx began a recall of SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB on 2023-04-25. FDA classified it as Class II and gives the reason as "Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a patient may cause injury or medical intervention to remove part of...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1970-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-25
Posted: 2023-06-15
Recalling firm: LumiraDx
Product: SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
Product code: KXG Applicator, Absorbent Tipped, Sterile
Reason for recall: Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a patient may cause injury or medical intervention to remove part of the swab
Root cause tag: manufacturing process
FDA root cause: Process control
Action: LumiraDx issued on 25 April 2023 via email electronic Cover Letter and Urgent Product Recall Notice with an attestation form to document product destruction at their facility. Letter states reason for recall, health risk and action to take: Immediately stop using the affected lot of swabs " Remove from your stock any remaining affected kits of swabs. " Destroy all stock of affected swabs " Indicate the number of packs that were destroyed, and sign the attestation form at the end of this notice verifying destruction of the affected swabs in your inventory. " Report any issues or adverse events with using the affected swabs to LumiraDx immediately or to the FDA via the MedWatch program. " Please forward this notice to additional testing sites if these products were further distributed within your system. " LumiraDx will provide replacement product after receipt of the attestation form. Please contact [email protected] to arrange overnight shipment. Please complete and return the enclosed product destruction and attestation form to LumiraDx as soon as possible. If you have any questions, contact LumiraDx Technical Services at [email protected] or 1-888-586-4721 option 1
Quantity in commerce: 1003 kits
Distribution: US Nationwide distribution.
Product codes and lots: GTIN-DI: 00850027193205 Pack Lot Number : 85438; Individual Swab Lot Number: 86445 Exp Date: 28-Oct-2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1970-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1970-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-15

Product code KXG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)