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Z-2438-2020 Class II Terminated

Recalled by Siemens Healthcare Diagnostics, Inc. — Tarrytown, NY

FDA device recall Z-2438-2020 was initiated by Siemens Healthcare Diagnostics, Inc. on May 15, 2020 and is designated Class II. Reason for recall: Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patient results if the QC failed but appeared … The recall status is terminated (terminated May 18, 2021). Affected quantity: 70 units.

Recall Details

Product Type
Devices
Report Date
July 8, 2020
Initiation Date
May 15, 2020
Termination Date
May 18, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
70 units

Product Description

(1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager software version 1.1 Siemens Material Number (SMN): 11316888 Product Usage: are clinical laboratory information modules which consolidate test orders and test results, provide test ordering and priority routing information to automation, apply rules to test orders and auto-verification rules for test results, and provide integrated management of quality control of test system.

Reason for Recall

Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patient results if the QC failed but appeared to be passing and the issue is not detected during QC review

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Bahamas, Belgium, Brazil, Chile, Colombia, Czech Republic, Egypt, Germany, Greece, Hungary, India, Italy, Kuwait, Latvia, Lithuania, Malaysia, Mexico, Oman, Peru, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom.

Code Information

Software versions: Atellica¿ Data Manager software version 1.0 UDI: 00630414234946 Atellica¿ Data Manager software version 1.1 UDI: 006304142790

Other recalls by Siemens Healthcare Diagnostics, Inc.

  • Z-2890-2026 Class II — Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic (July 6, 2026)
  • Z-2880-2026 Class III — Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catal (June 26, 2026)
  • Z-2881-2026 Class III — Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 (June 26, 2026)
  • Z-2703-2026 Class II — Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. (June 8, 2026)
  • Z-2398-2026 Class II — Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 107007 (May 7, 2026)
  • Z-2005-2026 Class II — epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Ma (April 2, 2026)
  • Z-1980-2026 Class II — Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. (March 18, 2026)
  • Z-1657-2026 Class II — Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11 (February 23, 2026)
  • Z-1484-2026 Class II — Atellica CH Urine Albumin (UAlb). Material Number: 11537225 (January 20, 2026)
  • Z-0492-2026 Class II — 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adj (October 6, 2025)

FDA data resources