COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Mini

FDA device recall Z-2440-2021 · posted 2021-09-09 · Terminated

Recall details

Recalling firm

Copan Italia

Reason for recall

A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano.

Action taken

On July 26, 2021, Copan Italia issued a "Urgent: Medical Device Recall" notification to all affected consignee. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. This notice should be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 2. Please identify, segregate, and discontinue use of all affected product included within ATTACHMENT #1_FLOQSwabs Recall product list . 3. Confirm you have read and understood the recall instructions provided in the letter in writing using the FORM #1_FLOQSwabs Recall Return Response , by email, to: Francisco Cuerva, Copan Diagnostics, Inc., 26055 Jefferson Avenue, Murrieta, CA US 92562, Phone: 800 216 4016 Ext. 204, InfoRecall@copanusa.net 4. Disposal must be performed according to local regulation and it does not require biohazard disposal precautions. Evidence or declaration of Product disposal must be returned in writing, using the FORM #2_FLOQSwabs Recall Disposal evidence , by email, to: Francisco Cuerva, Copan Diagnostics, Inc., 26055 Jefferson Avenue, Murrieta, CA US 92562, Phone: 800 216 4016 Ext. 204, InfoRecall@copanusa.net 5.If you are not in the position to identify, segregate or discard the Product you must advise in writing using the FORM #1_FLOQSwabs Recall Return Response , by email, to: Francisco Cuerva, Copan Diagnostics, Inc., 26055 Jefferson Avenue, Murrieta, CA US 92562, Phone: 800 216 4016 Ext. 204, InfoRecall@copanusa.net 6.This recall should be carried out to the end user level for all the affected Products that have been distributed including any products under private labeling, incorporated or utilized as kit components. 7. Any adverse events associated with recalled Product must be communicated in writing using the FORM #1_FLOQSwabs Recall Return Response , by email, to: Francisco Cuerva, Copan Diagnostics, Inc., 26055 Jefferson Avenue, Murri

Root cause

Vendor change control

Status

Terminated

Product code

KXG

Quantity affected

3,029,400 units

Distribution

US nationwide distribution, including Puerto Rico.

Date initiated

2021-07-09

Date posted

2021-09-09

Date terminated

2024-01-25

Location

Brescia, Italy