Z-1579-2016Class II

CF InPlex ASR Card; Catalog Number: 95-0501

Name: Z-1579-2016 CF InPlex ASR Card; Catalog Number: 95-0501
Creator: Hologic, Inc
Published: 2016-03-31
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2016-03-31 / Terminated / root cause: manufacturing process

FDA source

Hologic, Inc began a recall of CF InPlex ASR Card; Catalog Number: 95-0501 on 2016-03-31. FDA classified it as Class II and gives the reason as "Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1579-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-31
Posted: 2016-04-27
Terminated: 2016-08-09
Recalling firm: Hologic, Inc.
Product: CF InPlex ASR Card; Catalog Number: 95-0501.
Product code: NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Reason for recall: Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Customer notification letters were sent 03/31/16. Customers were instructed to immediately discontinue the use of the affected lot numbers. If a HET or MUT result was reported with the affected lots, Hologic recommends that customers notify the recipient of the result and request the patient be retested with another test method. Any HET or MUT results that were previously retested and reported out as negative do not require further testing. The firm requests that customers segregate any remaining inventory of all affected lots listed on the Customer Response Form. After segregation is complete reconcile the number of units (ASR Card or IVD Molecular Test Kit) which remain in inventory upon receipt of notification against the number originally shipped to site, and destroy all remaining inventory of the affected lots. Document the following in the appropriate fields on the Customer Response Form: 1. If have zero of the affected products on hand check the first box. 2. If have some inventory of the affected products on hand check the second box and then document the quantity on hand below, in the Qty On-Hand column. Note: When counting the number of units remaining in inventory count each unit (ASR Card box or IVD Molecular Test Kit), whether partial or full, as a unit. 3. Print name, phone and email address, in case the firm needs to follow up. 4. Sign and date the form. Signing acknowledges compliance with this recall notification, including destroying all remaining inventory of the affected products. When this documentation is complete fax the CRF to Hologic Technical Support using fax number: 858-410-8250. Alternatively, you can scan the document(s) and email to Hologic Technical Support at [email protected]. If laboratory has shared any of the affected cards noted in the CRF with another laboratory contact Hologic Technical Support immediately using the phone number below, so that Hologic may contact the other laboratory t
Quantity in commerce: 2580 total
Distribution: Distributed in the states of OH, AL, IL, AZ, AR, NJ, TX, GA, CO, DE, NC, MI, FL, ME, CA, IN, OR, KS, KY, MO, WA, NY, OK, WV, CT, IA, LA, RI, MA, and PA, and in the country of Canada.
Product codes and lots: Lot Numbers: U34xx U35xx (xx denotes sublots)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1579-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1579-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-27
Z-1580-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-27

Product code NUA

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)