CELL-DYN 07H77-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380740071141), received between Oct 11, 2016 and Nov 7, 2018 — classified as 8 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (K030513); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2018Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED MULTIPLE FALSELY DEPRESSED HEMOGLOBIN (HGB) RESULTS WHILE USING THE CELL-DYN 1800 ANALYZER. THE FOLLOWING DATA WAS PROVIDED. THE CUSTOMER USES NORMAL RANGE FOR MALE PATIENTS 13.2 TO 17.1 G/DL. PATIENT 1 5.00 G/DL, SYSMEX METHOD WAS HIGHER (10.0 G/DL); PATIENT 2 5.00 G/DL, SYSMEX METHOD WAS HIGHER (11.6 G/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8048634 ↗
• MalfunctionDec 22, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  THE CUSTOMER PROVIDED A PREVIOUS HEMOGLOBIN RESULT (10.0 G/DL) FOR THE PATIENT, HOWEVER THE SPECIFIC TEST DATE WAS NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7143853 ↗
• MalfunctionJun 8, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED WHITE BLOOD CELL (WBC) RESULTS WHILE USING THE CELL-DYN 1800 ANALYZER. THE FOLLOWING DATA WAS PROVIDED FOR ONE PATIENT. THE CUSTOMER USES REFERENCE RANGE 4.8 TO 10.8 K/UL. INITIAL 75.8, REPEAT 17.9 THE CUSTOMER STATED THE REPEAT RESULT WAS CONSISTENT WITH PATIENT HISTORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6624636 ↗
• MalfunctionFeb 9, 2017High Test Results; High Test Results

  THE CUSTOMER STATED THAT THE CD1800 ANALYZER GENERATED AN ELEVATED WBC RESULT OF 62,300/UL. THE SAMPLE WAS REPEATED ON ANOTHER CD1800 IN THE LAB AND A RESULT OF 9,900/UL WAS GENERATED. THE CUSTOMER PERFORMED AN AUTOCLEAN ON THE ORIGINAL ANALYZER AND REPEATED THE SAMPLE AND A RESULT OF 10,000/UL WAS GENERATED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6316167 ↗
• MalfunctionFeb 8, 2017High Test Results; High Test Results

  THE CUSTOMER REPORTED THE FOLLOWING RESULTS GENERATED ON A CELL-DYN 1800 ANALYZER IN THEIR LAB: HEMATOCRIT= 29.0%, HEMOGLOBIN= 9.3 G/DL. THE SAMPLE WAS TESTED AT ANOTHER LAB WITH THE FOLLOWING RESULTS (ANALYZER SYSTEM NOT PROVIDED): HEMATOCRIT= 28.7%, HEMOGLOBIN= 7.6 G/DL. CONTROLS HAVE REMAINED WITHIN SPECIFICATIONS. THE CUSTOMER RETESTED THE SAMPLE AGAIN WITH SIMILAR RESULTS. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6312684 ↗
• MalfunctionNov 14, 2016Low Test Results; Low Test Results

  THE ACCOUNT GENERATED FALSELY DEPRESSED HEMOGLOBIN ON A PATIENT SAMPLE PROCESSED MULTIPLE TIMES ON THE CELL-DYN 1800. INITIALLY, HEMOGLOBIN OF 9.0 G/DL BUT REPEATED 7.7, 7.0, 6.2, 5.6, 5.1 G/DL. THE ACCOUNT USES A NORMAL RANGE OF 12 TO 18 G/DL AND UNDER 8 G/DL IS CRITICAL LOW. THE SAMPLE WAS REPEATED ON THE CELL-DYN EMERALD WITH EXPECTED HEMOGLOBIN OF 11 G/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6098459 ↗
• MalfunctionOct 27, 2016High Test Results; High Test Results

  THE OBSERVED FALSELY ELEVATED WBC RESULTS ON THE CELL-DYN CD1800 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: WBC OF 99 K/UL, WHICH REPEAT IN THE NORMAL RANGE OF 4.6-10.2 K/UL. SID (B)(6) INITIAL WBC 47.1 K/UL, WHICH REPEATED IN THE NORMAL RANGE AND SID (B)(6) WBC 57.7 K/UL, WHICH ALSO REPEATED IN THE NORMAL RANGE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6061642 ↗
• MalfunctionOct 11, 2016Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY LOW HEMOGLOBIN (HGB) RESULTS FOR ONE PATIENT THAT WAS GENERATED USING THE CELL-DYN 1800 ANALYZER. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6) INITIAL 7.2 (NORMAL RANGE 14 TO 18 G/DL) DUE TO THE INITIAL LOW RESULT, THE PATIENT WAS REFERRED TO THE HOSPITAL. REPEAT USING CELL-DYN EMERALD ANALYZER (UNKNOWN SERIAL NUMBER) AT THE HOSPITAL FACILITY 8.1 (NORMAL RANGE (13.0 TO 16 G/DL). NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6018340 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030513. One submission often covers many models, so check the product and lot details in each record.

• Z-1698-2011 · Nov 30, 2009 · Terminated
  The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable are components that are used on one or more CELL-DYN Systems. Usage: Accessories to human waste con
• Z-1630-2010 · Jun 8, 2009 · Terminated
  CELL-DYN 1800, list numbers 07H77-01, 07H77-03, manufactured by Abbott Hematology, Santa Clara, CA
• Z-0455-2008 · Oct 27, 2006 · Terminated
  Abbott - CELL-DYN 1800 System with CELL-DYN 22 Calibrators and the CELL-DYN Calibrators and CELL-DYN 16 Controls. Part/Model Number: 07H77-01. Abbott Laboratories, Santa Clara, C