MAUDE Adverse Event Report: EURO DIAGNOSTICA AB DIASTAT ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL; ANA

Lot Number	TS 3577
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After shipment, stability test performed on the kit lot has shown that the kit functions as expected and hence the kit can be used through-out the original shelf-life.Therefore, the matter is deemed to not affect patient safety.Since the kit lot was already shipped with the shorter shelf-life, this expiry date must be adhered to, but since the new date is not stated on the alert sticker and the original kit box label remained on the kit box stating the original expiration date, it could be considered misbranding which is the reason for the recall.The recall decision was taken by the quality review board 2017-05-22.All affected countries regulatory authorities, as well as all affected euro diagnostica customers, have been notified of the recall.A field safety notice was sent out.The extent of the problem is presently deemed to be only fana200 ts 3577.
Event or Problem Description
Fana200 kit lot ts 3577 was re-worked due to shortened shelf-life.The alert sticker on the kit box of the lot informed customers that the shelf-life had been shortened and referenced a letter sent to customers for more information, where the new expiration date was stated.The original kit box label remained on the kit box stating the original expiration date.The alert sticker did not have the new expiration date stated on it.It has now come to euro diagnostica's attention that it would have been preferable to have had the new expiration date stated on the alert sticker.A recall of the lot has therefore been initiated.

• Brand Name: DIASTAT ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL
• Common Device Name: ANA
• Manufacturer (Section D): EURO DIAGNOSTICA AB; p. o. box 50117; malmo, skane 202 1 1; SW 202 11
• MDR Report Key: 6600314
• Report Number: 9616003-2017-00002
• Device Sequence Number: 18888508
• Product Code: LKJ
• UDI-Device Identifier: 07340058410486
• UDI-Public: 07340058410486
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K932876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Biomedical Engineer
• Device Expiration Date: 12/31/2017
• Device Lot Number: TS 3577
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2017
• Initial Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1