—#179477

Product

Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Humidity packs maintain reagent compartment humidity between 70100%. The operator loads 7 empty humidity packs initially.

FDA product code: N/A
Affected lot / code info: Lot 0010

Why it was recalled

A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.

Root cause (FDA determination)

Software in the Use Environment

Action the firm took

On January 7, 2020, the firm issued an Urgent Medical Device Correction letter to all affected US customers. Customers were informed that the analyzer may erroneously identify that humidity packs Lot 0100 have expired and eject them. The firm is investigating the root cause and customers will be notified when additional information is available. The behavior will be corrected in a new version of software that will be available shortly. It is important to note that Humidity Packs do have an onboard stability (OBS) of 180 days that is monitored by the system software. Once loaded onto an analyzer, the OBS of each pack is monitored. The firm is not recommending a review of previously generated results, since the accuracy of results is not affected by this issue. Customers were given workaround instructions so that they may manually enter the humidity packs.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: Domestic distribution nationwide. Foreign distribution worldwide.

Timeline

Recall initiated: 2020-01-06
Terminated: 2022-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179477. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.